Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000141044
Ethics application status
Approved
Date submitted
8/02/2010
Date registered
11/02/2010
Date last updated
11/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of the impact of nephrectomy on
cardiovascular risk in living kidney donors:
longitudinal follow-up. Focus on endothelial
dysfunction, inflammation and oxidative stress.
Scientific title
Assessment of the impact of nephrectomy on
cardiovascular risk in living kidney donors:
longitudinal follow-up. Focus on endothelial
dysfunction, inflammation and oxidative stress.
Secondary ID [1] 1397 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 256782 0
Condition category
Condition code
Renal and Urogenital 256927 256927 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this study is to assess the impact of nephrectomy on cardiovascular risk factors and vascular function, with emphasis on early markers of vasuclar disease including endothelial dysfunction, oxidative
stress and inflammation. Specifically, we will scrutinize the following features of early vascular disease:
Inflammation: hsC-reactive protein, Interleukin-6 (IL-6)
Endothelial dysfunction: Brachial Artery Reactivity
Smooth muscle dysfunction: Pulse Wave Velocity
Oxidative stress:Plasma, urinary 8-iso-prostaglandin 2 and oxidized low density lipoprotein (LDL)
Vascular structure: Carotid intima-media thickness
We will also collect data relevant to features of metabolic syndrome including triglyceride, High Density Lipoprotein, waist-hip ratio and fasting glucose, to determine the association between renal and cardiac function and traditional cardiovascular risk factors. All patients will be reviewed in outpatient clinic every 12 months for a total of 5 years. Data on vascular imaging studies will be collected at baseline and annually. Glomerular filtration rate will be estimated at baseline and annually using 24 hour urine collection, Modification of renal diet (MDRD) and 51Cr-Chromium-51 Ethylenediamine Tetraacetic acid (EDTA) nuclear scan. 24 hour urine collection will be used to measure urinary protein and albumin excretion. All cardiovascular events, admissions, biochemical and clinical data will be recorded at specific annually at time of follow up.
Intervention code [1] 255986 0
Not applicable
Comparator / control treatment
A control group already established within the Centre of Clinical Research and Excellence (CCRE), matched for age and gender will be approached for comparative purposes.
Control group
Active

Outcomes
Primary outcome [1] 257802 0
Carotid intima media thickness (ultrasound of vascular structure)
Timepoint [1] 257802 0
This study is planned for 5 years with baseline and subsequent review every 12 months.
Secondary outcome [1] 263216 0
Brachial artery reactivity (ultrasound of vascular function)
Timepoint [1] 263216 0
Baseline and every 12 months for 5 years

Eligibility
Key inclusion criteria
Patients who fulfill the live donation selection process and successfully complete donor nephrectomy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients from areas in Queensland where follow up vascular studies can not be carried out for logistic reasons.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256489 0
Government body
Name [1] 256489 0
National Health and Medical Research Council (NHMRC) (CCRE - Centres of Clinical Research Excellence)
Country [1] 256489 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
The University of Queensland Brisbane QLD 4072 Australia
Country
Australia
Secondary sponsor category [1] 255802 0
Hospital
Name [1] 255802 0
Nephrology Department, Princess Alexandra Hospital
Address [1] 255802 0
Ipswich Road, Woolloongabba Qld 4102
Country [1] 255802 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258540 0
Princess Alexandra Hospital
Ethics committee address [1] 258540 0
Ipswich Road, Woolloongabba Qld 4102
Ethics committee country [1] 258540 0
Australia
Date submitted for ethics approval [1] 258540 0
Approval date [1] 258540 0
Ethics approval number [1] 258540 0
2007/078

Summary
Brief summary
The aim of this study is to assess the impact of nephrectomy on cardiovascular risk factors and vascular function, with emphasis on early markers of vasuclar disease including endothelial dysfunction, oxidative stress and inflammation. The follow-up studies of donor safety are flawed by being retrospective and with significant loss to follow-up. The numbers of patients who have died or have significant cardiovascular disease have not been adequately assessed. In the general population any degree of renal impairment, eGFR < 60mls/min (Glomerular filtration rate) is independently associated with an increase in cardiovascular risk, death and hospitalization. Retrospective analysis or our cohort of live donors over the last 15 years (up till 2005) revealed that 39% of respondents had stage 2 (eGFR 15 -30mls/min) chronic kidney disease. We hypothesize that donors, post nephrectomy with the associated decrement in GFR may be at increased risk of future vascular disease. Specifically, we will scrutinize the following features of early vascular disease:
Inflammation: hsC-reactive protein, IL-6
Endothelial dysfunction: Brachial Artery Reactivity )
Smooth muscle dysfunction: Pulse Wave Velocity
Oxidative stress:Plasma, urinary 8-iso-prostaglandin 2 and oxidized LDL
Vascular structure: Carotid intima-media thickness
We will also collect data relevant to features of metabolic syndrome including triglyceride, High Density Lipoprotein, waist-hip ratio and fasting glucose, to determine the association between renal and cardiac function and traditional cardiovascular risk factors. This is a 5 year longituidinal study of live donors. All patients will be reviewed in outpatient clinic every 12
months. Data on vascular imaging studies will be collected at baseline and annually. Glomerular filtration rate will be estimated at baseline and annually using 24 hour urine collection, MDRD and 51Cr-EDTA nuclear
scan. 24 hour urine collection will be used to measure urinary protein and albumin excretion. All cardiovascular events, admissions, biochemical and clinical data will be recorded at specific annually at time of follow up. A control group (already established within the CCRE), matched for age and gender will be
approached for comparative purposes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30816 0
Address 30816 0
Country 30816 0
Phone 30816 0
Fax 30816 0
Email 30816 0
Contact person for public queries
Name 14063 0
Dr Nicole Isbel
Address 14063 0
Nephrology department, Princess Alexandra Hospital, Ipswich Road, Woolloongabba Qld 4102
Country 14063 0
Australia
Phone 14063 0
+61 7 3240 5080
Fax 14063 0
+61 7 3240 5480
Email 14063 0
[email protected]
Contact person for scientific queries
Name 4991 0
Dr Nicole Isbel
Address 4991 0
Nephrology department, Princess Alexandra Hospital, Ipswich Road, Woolloongabba Qld 4102
Country 4991 0
Australia
Phone 4991 0
+61 7 3240 5080
Fax 4991 0
+61 7 3240 5480
Email 4991 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.